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Experimental Medication For the Treatment of Generalized Anxiety Disorder

Primary Purpose

Anxiety Disorder

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
experimental anti-anxiety drug
Sponsored by
Jazz Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorder focused on measuring Double Blind, Placebo controlled, Safety and Efficacy, Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD. Exclusion Criteria: No other primary psychiatric diagnosis besides GAD.

Sites / Locations

  • Birmingham Research Group, Inc.
  • Crest Clinical Trials, Inc.
  • Southwesten Research, Inc.
  • Southwestern Research Institute
  • University of California - San Diego - Dept of Psychiatry
  • Clinical Innovations
  • Stanford University Medical Center
  • Diablo Clinical Research, Inc.
  • Alpine Clinical Research Center
  • New Britain General Hospital
  • Florida Clinical Research Center
  • ACT Clinical Research
  • University Clinical Research DeLand, Inc.
  • Sarkis Clinical Trials
  • Clinical Neuroscience Solutions, Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Meridien Research
  • Institute of Research in Psychiatry
  • Janus Center for Psychiatric Research
  • Atlanta Institute of Medicine and Research
  • Radiant Research
  • American Medical Research, Inc.
  • Peak Medical Research, LLC
  • New Orlean Medical Institute
  • Brentwood Research Institute
  • Pharmasite Research, Inc.
  • McLean Hospital
  • Pivotal Research Centers - Detroit
  • MedClin Research
  • CNS Research Institute (CRI)
  • ClinSearch, Inc.
  • Princeton Medical Institute
  • Social Psychiatry Research Institute
  • Midwest Clinical Research Center
  • Neurology and Neuroscience Center of Ohio
  • IPS Research Company
  • Laureate Psychiatric Clinic and Hospital
  • Oregon Center for Clinical Investigations, Inc.
  • Suburban Research Associates
  • CNS Research Institute
  • Southeast Health Consultants, LLC
  • CNS, Inc.
  • Clinical Research Associates, Inc.
  • FutureSearch Trials
  • Research Across America
  • R/D Clinical Research, Inc.
  • Lifetree Clinical Research
  • Comprehensive Neuroscience of Northern Virginia
  • Dominion Clinical Research, Inc.
  • Northwest Clinical Research Center

Outcomes

Primary Outcome Measures

Change in HAM-A Total Score
Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.

Secondary Outcome Measures

Full Information

First Posted
November 29, 2004
Last Updated
October 1, 2014
Sponsor
Jazz Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00097708
Brief Title
Experimental Medication For the Treatment of Generalized Anxiety Disorder
Official Title
A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Jazz Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.
Detailed Description
Protocol 04-001-01 The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD). The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication. Recruiting: Participants are currently being recruited and enrolled.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder
Keywords
Double Blind, Placebo controlled, Safety and Efficacy, Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
511 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
experimental anti-anxiety drug
Primary Outcome Measure Information:
Title
Change in HAM-A Total Score
Description
Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.
Time Frame
Baseline to week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD. Exclusion Criteria: No other primary psychiatric diagnosis besides GAD.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murray Stein, MD
Organizational Affiliation
University of California, San Diego
Official's Role
Study Chair
Facility Information:
Facility Name
Birmingham Research Group, Inc.
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Crest Clinical Trials, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
Southwesten Research, Inc.
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Southwestern Research Institute
City
Burbank
State/Province
California
ZIP/Postal Code
91506
Country
United States
Facility Name
University of California - San Diego - Dept of Psychiatry
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Innovations
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Alpine Clinical Research Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
New Britain General Hospital
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Florida Clinical Research Center
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
ACT Clinical Research
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
University Clinical Research DeLand, Inc.
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Meridien Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Institute of Research in Psychiatry
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Janus Center for Psychiatric Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Atlanta Institute of Medicine and Research
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Radiant Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
American Medical Research, Inc.
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Peak Medical Research, LLC
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42303
Country
United States
Facility Name
New Orlean Medical Institute
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Brentwood Research Institute
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Pharmasite Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Pivotal Research Centers - Detroit
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
MedClin Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63118
Country
United States
Facility Name
CNS Research Institute (CRI)
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
ClinSearch, Inc.
City
Kenilworth
State/Province
New Jersey
ZIP/Postal Code
07033
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Social Psychiatry Research Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Neurology and Neuroscience Center of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Laureate Psychiatric Clinic and Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
CNS Research Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19149
Country
United States
Facility Name
Southeast Health Consultants, LLC
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
CNS, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
FutureSearch Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Comprehensive Neuroscience of Northern Virginia
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22041
Country
United States
Facility Name
Dominion Clinical Research, Inc.
City
Midlothian,
State/Province
Virginia
ZIP/Postal Code
23112
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Experimental Medication For the Treatment of Generalized Anxiety Disorder

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